PMA P910056S035
- Device
- enVista Hydrophobic Acrylic Intraocular Lens
- Applicant
- Bausch & Lomb, Inc.
- PMA number
- P910056
- Supplement
- S035
- Product code
- HQL
- Decision date
- 2018-11-06
- Classification
- Intraocular Lens
- Generic name
- intraocular lens
- Approval order statement
- Change to the method of manufacturing the enVista® Hydrophobic Acrylic IOL, Model MX60E.
Current openFDA PMA Record#
- Device
- enVista Hydrophobic Acrylic Intraocular Lens
- Applicant
- Bausch & Lomb, Inc.
- PMA number
- P910056
- Supplement
- S035
- Product code
- HQL
- Generic name
- intraocular lens
- Decision date
- 2018-11-06
- Decision code
- OK30
- Date received
- 2018-10-16
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Change to the method of manufacturing the enVista® Hydrophobic Acrylic IOL, Model MX60E.